Tanezumab in Osteoarthritis Of The Hip

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00744471
First received: August 29, 2008
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients


Condition Intervention Phase
Arthritis
Osteoarthritis
Osteoarthritis, Hip
Biological: tanezumab
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Hip

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Womac Pain [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Arthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Womac Function [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Womac pain, physical function and stiffness; Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Sf-36 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Safety (laboratory, ECGs, vitals) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuations [ Time Frame: all weeks ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: daily to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 627
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 10 mg
Tanezumab 10 mg IV every 8 weeks
Biological: tanezumab
Tanezumab 10 mg IV every 8 weeks
Experimental: Tanezumab 5 mg
Tanezumab 5mg IV every 8 weeks
Biological: tanezumab
Tanezumab 5mg IV every 8 weeks
Experimental: Tanezumab 2.5 mg
Tanezumab 2.5 mg IV every 8 weeks.
Biological: tanezumab
Tanezumab 2.5 mg IV every 8 weeks.
Experimental: Placebo
Placebo
Biological: Placebo
Placebo to match tanezumab IV every 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the hip according to ACR criteria with Kellgren-Lawrence x-ray grade of 2
  • Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for Hip injections, arthroplasty or replacement surgery
  • Pain level and function levels as required by the protocol at Screening and Baseline
  • Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study
  • Must agree to the contraceptive requirements of the protocol if applicable
  • Must agree to the treatment plan, scheduled visits, and procedures of the protocol

Exclusion Criteria:

  • Pregnancy
  • BMI greater than 39
  • Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744471

  Show 88 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00744471     History of Changes
Other Study ID Numbers: A4091014
Study First Received: August 29, 2008
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014